BRILINTA CAN HAVE SIDE EFFECTS

BRILINTA can cause serious side effects, including risk of bleeding and shortness of breath.

While you take BRILINTA, you may bruise and bleed more easily and be more likely to have nosebleeds. Bleeding will also take longer than usual to stop. BRILINTA (and similar drugs) can cause bleeding that can be serious and sometimes lead to death. Instances of serious bleeding, such as internal bleeding, may require transfusions or surgery.

WHAT YOU NEED TO KNOW ABOUT BLEEDING WITH BRILINTA

BRILINTA is used to lower your chance of having another heart attack or dying from a heart attack or stroke, but BRILINTA (and similar antiplatelet drugs) can cause bleeding that can be serious and sometimes lead to death. In cases of serious bleeding, such as internal bleeding, the bleeding may result in the need for blood transfusions or surgery.

While you take BRILINTA:

You may bruise and bleed more easily

You are more likely to have nosebleeds

It will take longer than usual for any bleeding to stop

Here are some things you can do to help reduce the risk of bruising and bleeding while taking BRILINTA:

Add moisture to dry air, especially in the winter. This can help keep nostrils moist to avoid nosebleeds

Do not blow your nose hard

Practice extra caution to avoid bumps and bruises

Avoid activities where you can get hurt

Get plenty of rest

Drink plenty of fluids, eat a healthy diet, and exercise to help avoid constipation. Ask your doctor for a stool softener or laxative if you need one

Call your doctor right away if you experience any of these signs or symptoms of bleeding while taking BRILINTA:

Severe bleeding or uncontrollable bleeding

Pink, red, or brown urine

Vomit that is bloody or looks like coffee grounds

Red or black stool

Coughing up blood or blood clots

Do not stop taking BRILINTA without talking to the doctor who prescribes it for you. People who are treated with a stent, and stop taking BRILINTA too soon, have a higher risk of getting a blood clot in the stent, having a heart attack, or dying. If you stop BRILINTA because of bleeding or for other reasons, your risk of a heart attack or stroke may increase.

Your doctor may instruct you to stop taking BRILINTA 5 days before surgery. This will help to decrease your risk of bleeding with your surgery or procedure. Your doctor should tell you when to start taking BRILINTA again, as soon as possible after surgery.

Shortness of breath: Call your doctor if you have new or unexpected shortness of breath when you are at rest, at night, or when you are doing any activity. Your doctor can decide what treatment is needed.

Other common side effects with BRILINTA include dizziness, nausea, diarrhea, slow heartbeat rate, rash, and allergic reactions including swelling of the face, throat, lips, tongue, hands, or feet.

WHO SHOULD NOT TAKE BRILINTA?

Do not take BRILINTA if you:

IMPORTANT SAFETY INFORMATION ABOUT BRILINTA® (ticagrelor), INCLUDING BOXED WARNINGS, FOR 60-MG AND 90-MG TABLETS Read More

BRILINTA is used to lower your chance of having another heart attack or dying from a heart attack or stroke, but BRILINTA (and similar drugs) can cause bleeding that can be serious and sometimes lead to death. Instances of serious bleeding, such as internal bleeding, may require blood transfusions or surgery. While you take BRILINTA, you may bruise and bleed more easily and be more likely to have nosebleeds. Bleeding will also take longer than usual to stop.

Approved Use

BRILINTA is a prescription medicine for people who have had a heart attack or severe chest pain that happened because their heart wasn’t getting enough oxygen.

IMPORTANT SAFETY INFORMATION ABOUT BRILINTA® (ticagrelor), INCLUDING BOXED WARNINGS, FOR 60-MG AND 90-MG TABLETS

BRILINTA is used to lower your chance of having another heart attack or dying from a heart attack or stroke, but BRILINTA (and similar drugs) can cause bleeding that can be serious and sometimes lead to death. Instances of serious bleeding, such as internal bleeding, may require blood transfusions or surgery. While you take BRILINTA, you may bruise and bleed more easily and be more likely to have nosebleeds. Bleeding will also take longer than usual to stop.

Call your doctor right away if you have any signs or symptoms of bleeding while taking BRILINTA, including: severe, uncontrollable bleeding; pink, red, or brown urine; vomit that is bloody or looks like coffee grounds; red or black stool; or if you cough up blood or blood clots.

Do not stop taking BRILINTA without talking to the doctor who prescribes it for you. People who are treated with a stent, and stop taking BRILINTA too soon, have a higher risk of getting a blood clot in the stent, having a heart attack, or dying. If you stop BRILINTA because of bleeding, or for other reasons, your risk of a heart attack or stroke may increase. Tell all your doctors and dentists that you are taking BRILINTA. To decrease your risk of bleeding, your doctor may instruct you to stop taking BRILINTA 5 days before you have surgery. Your doctor should tell you when to start taking BRILINTA again, as soon as possible after surgery.

Take BRILINTA and aspirin exactly as instructed by your doctor. You should not take a dose of aspirin higher than 100 mg daily because it can affect how well BRILINTA works. Tell your doctor if you take other medicines that contain aspirin. Do not take new medicines that contain aspirin.

Do not take BRILINTA if you have a history of bleeding in the brain, are bleeding now, or are allergic to ticagrelor or any of the ingredients in BRILINTA.

Slow heart rhythm has been reported with BRILINTA.

BRILINTA can cause serious side effects, including bleeding and shortness of breath. Call your doctor if you have new or unexpected shortness of breath or any side effect that bothers you or that does not go away. Your doctor can decide what treatment is needed.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BRILINTA may affect the way other medicines work, and other medicines may affect how BRILINTA works. Tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while being treated with BRILINTA.

APPROVED USE

BRILINTA is a prescription medicine for people who have had a heart attack or severe chest pain that happened because their heart wasn’t getting enough oxygen.

BRILINTA is used with aspirin to lower your chance of having another serious problem with your heart or blood vessels such as heart attack, stroke, or blood clots in your stent if you received one. These can be fatal.

The information on this Web site should not take the place of talking with your doctor or health care professional. If you have any questions about your condition, or if you would like more information about BRILINTA, talk to your doctor or pharmacist. Only you and your health care professional can decide if BRILINTA is right for you.